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Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

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ClinicalTrials.gov Identifier: NCT02789644
Recruitment Status : Unknown
Verified May 2016 by Jae Yong Chung, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Hospital

Brief Summary:
A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Condition or disease Intervention/treatment Phase
Aged Drug: Ursodeoxycholic Acid Phase 1

Detailed Description:
This study has a randomized, open-label, two-treatment, one-sequence, multiple drug administration design. The purpose of this study is as follows; To investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Healthy Elderly Subjects After Ursodeoxycholic Acid Administration
Study Start Date : May 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

Arm Intervention/treatment
Experimental: Ursodeoxycholic acid 400mg
Day 1: Ursodeoxycholic acid 400mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Drug: Ursodeoxycholic Acid
Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Other Name: Ursa tab.

Experimental: Ursodeoxycholic acid 800mg
Day 1: Ursodeoxycholic acid 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Drug: Ursodeoxycholic Acid
Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Other Name: Ursa tab.




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid [ Time Frame: predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 84 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Subjects aged 70 - 84 years
  • A body mass index (BMI) in the range of 18.5 kg/m2 - 29.9 kg/m2.
  • Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

  • Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
  • Subject judged not eligible for study participation by investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789644


Contacts
Contact: Jae-Yong Chung, M.D., Ph.D +82-031-787-3955

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae-Yong Chung, MD, PhD    +82-031-787-3955      
Principal Investigator: Jae-Yong Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jae-Yong Chung, M.D., Ph.D Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital

Responsible Party: Jae Yong Chung, M.D., Ph.D, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02789644     History of Changes
Other Study ID Numbers: UDCA_elderly
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jae Yong Chung, Seoul National University Hospital:
Ursodeoxycholic acid
Metabolomics/biomarker
Pharmacokinetics

Additional relevant MeSH terms:
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents